GaleMed Corporation

Certificate HZ 2100418-1

Rev. 2Issued

Valid until: May 8, 2028

Certificate HZ 2100418-1 is a valid Quality management system issued to GaleMed Corporation and registered in EUDAMED. Valid until May 8, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2100418-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2100418-12

Validity

Issued: Nov 13, 2023
Valid from: Nov 13, 2023
Valid until: May 8, 2028

Manufacturer

Manufacturer: GaleMed Corporation
Manufacturer SRN: TW-MF-000022411
Manufacturer country: Taiwan

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIa1

2 scopes

Z121501 - SPIROMETRY INSTRUMENTS
Class I
R020101 - STANDARD BREATHING CIRCUITS R020102 - COAXIAL BREATHING CIRCUITS R020104 - CPAP AND NIV BREATHING CIRCUITS R020106 - IPPB CIRCUITS R030101 - VENTILATION MASKS R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS R030103 - AEROSOL THERAPY MASKS AND SYSTEMS R030202 - MANUALLY OPERATED VENTILATION BALLOONS R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS R060202 - OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
Class IIa

Documents

LanguagesEN